Unique ID issued by UMIN | UMIN000043491 |
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Receipt number | R000049592 |
Scientific Title | Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity |
Date of disclosure of the study information | 2021/05/01 |
Last modified on | 2021/03/01 19:16:05 |
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Japan |
Not applicable (Healthy adults)
Adult |
Others
NO
To investigate a sample collection method for quantitative evaluation of the abundance of Fusobacterium nucleatum in the oral cavity of healthy subjects.
Others
Research
Exploratory
Not applicable
Quantification of the number of Fusobacterium nucleatum and Fusobacterium spp. in oral specimens.
Quantitative evaluation focusing on a specific strain.
Detection and quantification of pathogenic genes of Fusobacterium nucleatum.
16S rRNA gene-based or shotgun metagenome analysis.
Observational
20 | years-old | <= |
65 | years-old | >= |
Male and Female
Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
1. Subjects who have participated in other clinical trials requiring oral health care within 3 months prior to obtaining consent or are currently participating in other clinical trials.
2. Subjects with dentures (including implants) or undergoing orthodontic treatment.
3. Subjects who consumed antibiotics during last 3 months.
4. Subjects with serious or progressive diseases or conditions.
5. Subjects who are currently visiting a dentist or receiving treatment within 3 months prior to obtaining consent (any treatment related to teeth or gums).
6. Subjects who have been determined ineligible by principal investigator or study administrator.
7. Subjects who routinely consume medicines, health foods, supplements, food for specified health uses, or functional foods that affect the oral environment.
8. Subjects with a current or previous food or drug allergy.
9. Smoker
10. Subjects who have excessive drinking habits.
11. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the study period.
6
1st name | Mitsuharu |
Middle name | |
Last name | Matsumoto |
Kyodo Milk Industry Co. Ltd.
Research Laboratories
190-0182
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
042-597-5911
m-matumoto@meito.co.jp
1st name | Naomi |
Middle name | |
Last name | Yuzawa |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
n-yuzawa@imeqrd.co.jp
Kyodo Milk Industry Co. Ltd.
Kyodo Milk Industry Co. Ltd.
Profit organization
Iryouhoujinsyadan Hakusuikai, Suda Clinic institutional review board
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
協同乳業株式会社研究所
2021 | Year | 05 | Month | 01 | Day |
Unpublished
Preinitiation
2021 | Year | 02 | Month | 18 | Day |
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 03 | Month | 08 | Day |
2021 | Year | 06 | Month | 01 | Day |
Study Design: Research
Subject Recruitment: Subjects who meet the selection criteria and do not meet the exclusion criteria will be selected from healthy adult volunteers.
Main items to be measured: The number of Fusobacterium nucleatum in oral specimens.
2021 | Year | 03 | Month | 02 | Day |
2021 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049592
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